SANDMAN

Standard Polysomnograph With Electroencephalograph

MELVILLE SOFTWARE LTD.

The following data is part of a premarket notification filed by Melville Software Ltd. with the FDA for Sandman.

Pre-market Notification Details

• Device ID: K934599
• 510k Number: K934599
• Device Name: SANDMAN
• Classification: Standard Polysomnograph With Electroencephalograph
• Applicant: MELVILLE SOFTWARE LTD. 350 SPARKS ST. SUITE 1007 Ottawa, Ontario, CA K1r 7s8
• Contact: David N Baker
• Correspondent: David N Baker; MELVILLE SOFTWARE LTD. 350 SPARKS ST. SUITE 1007 Ottawa, Ontario, CA K1r 7s8
• Product Code: OLV
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-09-24
• Decision Date: 1994-01-27
• Summary: summary